NCT00165854

Brief Summary

Part 1: The primary purpose is to determine the recommended dose of E7070 in combination with capecitabine by dose adjustment. Part 2: The primary purpose is to determine the safety and efficacy of the combination in patients with metastatic CRC resistant to 5-fluorouracil and irinotecan.

Trial Health

85
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
46

participants targeted

Target at P25-P50 for phase_2

Geographic Reach
3 countries

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2003

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 14, 2005

Completed
Last Updated

June 27, 2014

Status Verified

October 1, 2006

First QC Date

September 13, 2005

Last Update Submit

June 26, 2014

Conditions

Colorectal Cancer (CRC)

Outcome Measures

Primary Outcomes (2)

  • To determine the recommended dose of E7070 in combination with capecitabine by dose adjustment;

  • to determine the safety, tolerability and efficacy (in terms of response rate and progression-free survival) of the combination in patients with metastatic CRC.

Secondary Outcomes (2)

  • Determine the pharmacokinetic profile of capecitabine and E7070 when administered in combination;

  • measure duration of response and stable disease; to measure median and one year survival.

Interventions

E7070DRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Histologically or cytologically confirmed solid tumour refractory to standard therapy or for whom no established therapy exists
  • Age \>= 18 years
  • Karnofsky performance status of \>= 70%
  • Life expectancy of \>= 3 months
  • Absolute neutrophil count of \>= 1.5 × 109/l, platelet count of ³ 100 × 109/l, haemoglobin level of ³ 10 g/dl (\>= 6.2 mmol/l) (prior transfusion is permitted)
  • Normal hepatic and renal function as defined by serum bilirubin £ 1.5 times the upper limit of normal, ALT and AST £ 2.5 times the upper limit of normal (£ 5 times the upper limit of normal in the presence of hepatic metastases), creatinine clearance ³ 50 ml/min (by Cockroft-Gault formula)
  • Male and female patients
  • Written informed consent to participate in the study

You may not qualify if:

  • More than two previous courses of documented myelosuppresive chemotherapy (epidermal growth factor targeted therapy does not constitute a course of chemotherapy)
  • CNS metastases (a CT or MRI scan should be done if there is a clinical suspicion of CNS metastases)
  • Major surgery, chemotherapy or radiation therapy (except palliative) within 4 weeks of treatment start
  • Previous investigational cytotoxic treatment for malignant disease within 30 days before the start of the study
  • Any treatment with non-oncological investigational drugs within 30 days before the start of the study
  • Fertile males not willing to use contraception or whose female partners are not using adequate contraceptive protection
  • Uncontrolled infections
  • Clinically significant cardiac impairment or unstable ischaemic heart disease including a myocardial infarction within three months of study entry
  • History of alcoholism, drug addiction, or any psychiatric or psychological condition which in the opinion of the investigator would impair study compliance
  • History of hypersensitivity to sulphonamides
  • Prior severe or unexpected reaction to fluoropyrimidine therapy (which may be explained by dihydropyrimidine dehydrogenase deficiency or hypersensitivity to 5-FU)
  • Malabsorption syndrome or other condition which may affect absorption of drug
  • Concurrent or previous malignancy of a different tumour type within five years of starting the study except for adequately treated non-melanoma skin cancer or cervical intraepithelial neoplasia
  • Treatment within two weeks before the start of the study with any of the following: coumarin anti-coagulants, terfenadine, cisapride, cyclosporin, tacrolimus, theophylline, diazepam, sulphonylurea hypoglycaemics, phenytoin, or carbamazepine
  • Legal incapacity
  • +24 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Centre Léon Bérard

Lyon, F-69373, France

Location

Institut Curie

Paris, F-75005, France

Location

Universitätsklinikum der GHS-Essen

Essen, D-45122, Germany

Location

Netherlands Cancer Institute

Amsterdam, 1066 CX, Netherlands

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

N-(3-chloro-7-indolyl)-1,4-benzenedisulphonamide

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Study Officials

  • Jantien Wanders

    Eisai Limited

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 14, 2005

Study Start

March 1, 2003

Last Updated

June 27, 2014

Record last verified: 2006-10

Locations

NL(1)FR(2)DE(1)